NCT04730349|TerminatedPhase 1ResultsDMCFDA Drug

Study Stopped

Business objectives have changed

A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer

PIVOT IO 020

Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA045-0202020-000854-85

Study Type

interventional

Target

Locations

6 countries

Sites

Timeline

RegisteredJan 2021

StartedJun 2021

CompletionJun 2022

Brief Summary

The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started Jun 2021

Geographic Reach

6 countries

18 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

January 26, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed

4 months until next milestone

Study Start

First participant enrolled

June 3, 2021

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed

9 months until next milestone

Results Posted

Study results publicly available

March 24, 2023

Completed

Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

January 26, 2021

Results QC Date

December 21, 2022

Last Update Submit

March 22, 2023

Conditions

Ependymoma Ewing Sarcoma High-grade Glioma Leukemia and Lymphoma Medulloblastoma Miscellaneous Brain Tumors Miscellaneous Solid Tumors Neuroblastoma Relapsed, Refractory Malignant Neoplasms Rhabdomyosarcoma

Keywords

B-cell leukemia/lymphoma/non-Hodgkin lymphoma (NHL)BEMPEGBempegaldesleukinCD122-Biased AgonistCD122-Biased CytokineCheck point inhibitorEpendymomaEwing sarcomaHigh-grade glioma (HGG)/diffuse intrinsic pontine glioma (DIPG)ImmunotherapyIL-2IL-2 Receptor AgonistLeukemia and lymphomaMedulloblastomaMelanomaMiscellaneous brain tumorsMiscellaneous solid tumorsNeuroblastomaNivolumabNKTR-214NIVONon-rhabdomyosarcoma soft-tissue sarcomasOpdivo®Pediatric cancerPediatric malignancyRhabdomyosarcoma

Outcome Measures

Primary Outcomes (9)

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy).
From first dose to 42 days after first dose
Number of Participants With Adverse Events (AEs) - Part A
Number of participants with adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants With Serious Adverse Events (SAEs) - Part A
Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants With Drug-Related Adverse Events - Part A
Number of participants with drug-related adverse events. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants With Adverse Events Leading to Discontinuation - Part A
Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants Who Died - Part A
Number of participants who died.
From first dose to 30 days after last dose (up to approximately 6 months)
Maximum Observed Plasma Concentration (Cmax) - Part A
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
From first dose to 30 days after last dose (up to approximately 6 months)
Trough Observed Concentration (Ctrough) - Part A
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
From first dose to 30 days after last dose (up to approximately 6 months)
Area Under the Plasma Concentration (AUC) - Part A
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
From first dose to 30 days after last dose (up to approximately 6 months)